Associate Director Pharmacoepidemiology

Job Description

The Associate Director will be responsible for managing pharmacoepidemiologic projects and activities with limited direction in support of marketed and/ or development compounds, commensurate with experience/ skill, in accordance with global regulations and Regeneron SOPs and working practices. Serve as in-house resource on pharmacoepidemiology to other departments. The candidate should be knowledgeable in the latest epidemiologic methods and resources to be able to be responsive within cross functional teams and to guide decision making where needed.

Responsibilities:

Under supervision of the Pharmacoepidemiology TA lead:

Responsible for implementation of pharmacoepidemiology strategy, generation of real world evidence (RWE), and conduct of regulatory-agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements

Actively contribute to other pharmacoepidemiologic activities as a subject matter expert for assigned marketed / development compound(s) or TAs, including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; post-approval safety studies that may not be required by a regulatory authority; signal management; responses to regulatory agency queries; regulatory filings, safety surveillance and others

Working closely with Global Patient Safety Leads, Safety Scientists, Regulatory Affairs, Clinical Scientists and other interested parties, provide timely epidemiological and risk management support to project and product teams including design, implementation and analysis of epidemiological studies, review of study proposals from internal and external sources, reviews of the literature, and database activities such as exploring external electronic, patient-level database(s) (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, disease natural history, and other appropriate epidemiologic data in support of clinical development and regulatory filings

Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed

Manage and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)

Actively participate in process improvement activities within the department and Global Patient Safety (GPS) as needed

JOB REQUIREMENTS:

• Function as a subject matter expert on pharmacoepidemiology for assigned compounds/projects with proven history of working on diverse and complex matters.
• Up-to-date knowledge of US and international regulatory guidances (e.g., pharmacovigilance, RWE, good epidemiology practices) and ability to apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle.
• Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities Significant experience working with cross-functional teams and external vendors.
• Excellent written and verbal communication skills
• Proven track record of interpersonal, leadership, and project management skills
• Doctoral degree in epidemiology or a related field, generally with 3+ years of relevant post-doctoral experience. Industry/Regulatory experience preferred.
• Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 5+ years of relevant experience. Industry/Regulatory experience preferred.
• Demonstrated achievements of increasing complexity/ responsibility.